PHS Guideline on Infectious Disease Issues in Xenotransplantation

Forms and Documents

Document Name	Status
0456SUPPORTINGSTATEXeno2022 4-04-22.docx Supporting Statement A	2022-04-04

IC Document Collections

IC ID	Document Title	Status
6147	Notification to FDA when source facility or sponsor ceases operations Other-PHS Guideline	Modified
204794	Disclosures to sponsors Other-PHS Guideline	Modified
204780	Xenotransplantation Recordkeeping Other-PHS Guideline	Modified

ICR Details

OMB Control No: 0910-0456	ICR Reference No: 202109-0910-004
Status: Received in OIRA	Previous ICR Reference No: 201906-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: PHS Guideline on Infectious Disease Issues in Xenotransplantation
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/26/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2022
Responses	216	216
Time Burden (Hours)	59	60
Cost Burden (Dollars)	3,922	3,922

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Abstract: This information collection supports implementation of sections 351 and 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 262 and 264) and certain drug provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), regarding xenotransplantation. As set forth in the “PHS Guideline on Infectious Disease Issues in Xenotransplantation,” guidelines were developed by the Public Health Service (PHS) to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a risk to public health. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: Federal Food Drug and Cosmetic Act
   US Code: 42 USC 264 Name of Law: Public Health Service Act
   US Code: 42 USC 262 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 58666	10/22/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 24316	04/25/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Disclosures to sponsors
Notification to FDA when source facility or sponsor ceases operations
Xenotransplantation Recordkeeping

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	216	216	0	0	0	0
Annual Time Burden (Hours)	59	60	0	0	-1	0
Annual Cost Burden (Dollars)	3,922	3,922	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The previous total estimated annual burden was 59.03 hours. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate other than to adjust total burden hours by one hour, from 60 to 59 total burden hours, to address an inadvertent error in disclosure burden in the previous submissions to OMB.

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Annual Cost to Federal Government: $4,880

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/26/2022

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